Synta Reports Fourth Quarter and Year-End 2014 Financial Results
- GALAXY-2 Clinical Trial On Track for Interim Analysis in Second Half of 2015 –
- 500 Patients Enrolled To Date -
Webcast and Conference Call Today,
“This past year has been marked by both significant progress and change
for the organization. With new leadership and a renewed focus, we are
laying the foundation for building a leading oncology biopharmaceutical
company and realizing the value of our lead clinical candidate,
ganetespib, and our proprietary Hsp90 inhibitor Drug Conjugate program,”
said
2014 Accomplishments and Recent Updates
-
Final Results from GALAXY-1 Reported; GALAXY-2 Clinical Trial
Remains on Track for Interim Analysis of Overall Survival in 2015. In
2014, Synta announced final results from the global, randomized,
multi-center Phase 2b GALAXY-1 study comparing the combination of
ganetespib and docetaxel to docetaxel alone for the second-line
treatment of advanced non-small cell adenocarcinoma. The final results
from this trial, in particular the encouraging overall survival
results and tolerability profile in patients whose time from diagnosis
of advanced disease is greater than 6 months, support the selection of
this population for the ongoing pivotal Phase 3 GALAXY-2 trial.
Five hundred (500) patients have been enrolled in GALAXY-2 to date. The Company expects, based on current projections and statistical assumptions, that the first interim overall survival (OS) analysis of GALAXY-2 will be conducted in the second half of 2015, and the second interim and final OS analysis will be conducted in 2016. Assuming positive interim results from the ongoing GALAXY-2 trial of ganetespib, and pending regulatory feedback, the Company plans to seek regulatory approval of ganetespib inNorth America andEurope for NSCLC in 2016.
-
Results from ENCHANT-1 Trial Lead to Selection of Ganetespib for
I-SPY 2 Breast Cancer Trial; Enrollment of Ganetespib Arm Ongoing. In
2014, the Company announced results from the ENCHANT-1 trial, a
single-arm multi-center Phase 2 proof-of-concept study designed to
evaluate ganetespib administered as monotherapy for the treatment of
metastatic breast cancer at the 2014
European Breast Cancer Conference (EBCC). The results demonstrated encouraging single-agent activity in both HER2+ and triple-negative disease. The strength of the scientific rationale and evidence of clinical activity in ENCHANT-1 led to the selection of ganetespib for the I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2). I-SPY 2 is a standing Phase 2 randomized, controlled, multicenter trial for women with newly diagnosed, locally advanced breast cancer (Stage 2 or higher) that is designed to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neoadjuvant setting. The trial is sponsored by QuantumLeap Healthcare Collaborative, a 501(c)(3) non-profit organization dedicated to accelerating healthcare solutions, and shares a unique partnership with theFoundation for the National Institutes of Health Biomarkers Consortium .
-
Ganetespib Advances into Phase 3 Extension of AML LI-1 Study in
AML and High-Risk MDS; Selected for Randomized AML-18 and AML-19
Trials. The Company announced the advancement of ganetespib
into the Phase 3 extension of the AML LI-1 trial after meeting
pre-specified interim efficacy analysis criteria in
July 2014 . The multicenter randomized Phase 2/3 AML LI-1 (less intensive) trial, being conducted under the auspices of the UK’sNational Cancer Research Institute (NCRI) Haematological Oncology Study Group ,UK , and under the sponsorship ofCardiff University , is evaluating treatments in newly diagnosed patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) over 60 years of age who are not eligible for intensive chemotherapy. Two additional, randomized Phase 2/3 AML trials, supported by the same sponsors, will evaluate ganetespib in combination with chemotherapy in first-line treatment of patients with AML and high risk MDS: AML-18 and AML-19. Initiation of the AML-18 trial was announced in the fourth quarter of 2014; AML-19 is expected to initiate in the first half of 2015. -
Initiation of Phase 2 Portion of GANNET53 Trial in Ovarian
Cancer Anticipated in First Half 2015; Phase 1 Portion Complete. In
July 2014 , GANNET53, a randomized, Phase 1/2 trial in metastatic, platinum-resistant ovarian cancer and a Seventh Framework Programme (FP7) research project funded by theEuropean Commission , commenced enrollment in the safety lead-in Phase 1 portion evaluating the combination of ganetespib and paclitaxel. Enrollment is now complete and investigators plan to present results from the Phase 1 portion at a medical meeting in 2015. Initiation of the randomized Phase 2 portion, which will evaluate the combination of ganetespib and paclitaxel vs. paclitaxel alone in over 200 patients, is anticipated in the first half of 2015. -
Company Invited to ODAC Pediatric Subcommittee Meeting To
Discuss Ganetespib in Pediatric Sarcoma. The Company was
invited by the
U.S. Food and Drug Administration (FDA ) to participate in aDecember 2014 meeting of the Oncologic Drugs Advisory Committee’s (ODAC) Pediatric Subcommittee to discussFDA issuance of a Pediatric Written Request to Synta. At the meeting, the subcommittee reviewed the SARC 023 study, an open label Phase 1/2 trial of ganetespib in combination with the mTOR inhibitor sirolimus in patients with refractory sarcoma, including malignant peripheral nerve sheath tumors (MPNSTs), sponsored by theSarcoma Alliance for Research through Collaboration (SARC). -
First Candidate from
Hsp90 Inhibitor Drug Conjugate (HDC) Program Advancing Toward Clinic . The Company presented preliminary preclinical data from its HDC Program at scientific meetings throughout 2014, including poster presentations at the 105th Annual Meeting of theAmerican Association for Cancer Research (AACR) in April and the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in November. Results presented at these meetings demonstrate the prolonged antitumor effects and broad activity of the Company’s lead HDC candidate, STA-12-8666, a conjugate of an Hsp90 inhibitor and SN-38, the active metabolite of the widely used drug irinotecan, across several tumor types. The data also highlighted the feasibility of constructing HDCs using several classes of payloads. In the first quarter of 2015, the Company advanced STA-12-8666 into IND enabling studies. A submission of an IND for STA-12-8666 is anticipated by the first quarter of 2016. -
Executive Management Team Strengthened; New Corporate Strategy
Outlined. In 2014, the Company strengthened its executive
management team and Board of Directors through the appointment of
Anne C. Whitaker as President, Chief Executive Officer and Member of the Board of Directors;Paul A. Friedman , M.D., as Director;Chen Schor as Executive Vice President and Chief Operating Officer; and Marc R. Schneebaum as Senior Vice President, Chief Financial Officer. InFebruary 2015 , Synta outlined a new strategy for transforming the company into a leading oncology biopharmaceuticals company. The strategy highlighted divestiture of non-core programs, a more focused research program, and the reallocation of resources with an emphasis on value creating milestones in 2015 and 2016 with ganetespib and its HDC product candidates.
Fourth quarter and full year 2014 financial results
There were no revenues recognized in the fourth quarters of 2014 and
2013. There were no revenues recognized for either the year ended
Research and development expenses were
General and administrative expenses were
The Company reported a net loss of
As of
More detailed financial information and analysis may be found in the
Company's Annual Report on Form 10-K for the year ended
Guidance
The Company expects its cash resources of approximately
Conference call
Synta will host a conference call at
The conference call can be accessed by dialing (877) 407-8035 (U.S.) or
(201) 689-8035 (International). For those unable to join the live call,
a replay will be available from
The live webcast
can be accessed by visiting the Investor
Relations section of the
About
Synta Pharmaceuticals Corp. is an innovative, agile biopharmaceutical company focused on research, development and commercialization of novel oncology medicines that change cancer patients’ lives. Synta’s lead oncology drug candidate, ganetespib, a novel heat shock protein 90 (Hsp90) inhibitor, is currently being evaluated in several clinical trials including the pivotal GALAXY-2 Phase 3 trial in non-small cell lung cancer. Building on its extensive expertise in the science of Hsp90, Synta also has a novel proprietary Hsp90 inhibitor Drug Conjugate (HDC) small molecule drug development program. IND enabling studies have commenced for the first clinical candidate from the HDC program, STA-12-8666, and preclinical evaluation of additional HDC candidates is ongoing. For more information, please visit www.syntapharma.com.
Safe Harbor Statement
This media release may contain forward-looking statements about
Synta Pharmaceuticals Corp. Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (unaudited) |
||||||||||||||||||
Three Months Ended December 31, |
Twelve Months Ended December 31, |
|||||||||||||||||
2014 |
2013 |
2014 |
2013 |
|||||||||||||||
Revenues: | ||||||||||||||||||
Total revenues |
$ | — |
$ |
— | $ | — | $ | — | ||||||||||
Operating expenses: |
||||||||||||||||||
Research and development | 15,653 | 19,981 | 68,205 | 71,860 | ||||||||||||||
General and administrative | 4,241 | 3,463 | 15,746 | 15,699 | ||||||||||||||
Total operating expenses | 19,894 | 23,444 | 83,951 | 87,559 | ||||||||||||||
Loss from operations | (19,894 | ) | (23,444 | ) | (83,951 | ) | (87,559 | ) | ||||||||||
Interest expense, net | (458 | ) | (718 | ) | (2,210 | ) | (2,633 | ) | ||||||||||
Net loss | $ | (20,352 | ) | $ | (24,162 | ) | $ | (86,161 | ) | $ | (90,192 | ) | ||||||
Basic and diluted net loss per common share | $ | (0.19 | ) | $ | (0.31 | ) | $ | (0.87 | ) | $ | (1.27 | ) | ||||||
Basic and diluted weighted average number of common shares outstanding | 108,366,504 | 76,769,199 | 98,489,470 | 70,976,705 | ||||||||||||||
Synta Pharmaceuticals Corp. Condensed Consolidated Balance Sheets Data (in thousands) (unaudited) |
|||||||
December 31,
2014 |
December 31,
2013 |
||||||
Assets | |||||||
Cash, cash equivalents and marketable securities | $ | 97,690 | $ | 91,476 | |||
Other current assets | 1,656 | 765 | |||||
Property, plant and equipment, net | 1,024 | 1,553 | |||||
Other non-current assets | 305 | 1,409 | |||||
Total assets | $ | 100,675 | $ | 95,203 | |||
Liabilities and Equity | |||||||
Current liabilities | $ | 30,889 | $ | 32,207 | |||
Long-term liabilities | 4,650 | 13,905 | |||||
Stockholders’ equity | 65,136 | 49,091 | |||||
Total liabilities and
Stockholders’ equity |
$ |
100,675 |
$ |
95,203 |
|||
Source:
Investors:
Synta Pharmaceuticals Corp.
Daniel Cole,
781-541-7250
[email protected]
or
Argot
Partners
Andrea Rabney, 212-600-1494
[email protected]
or
Media:
Argot
Partners
Eliza Schleifstein, 917-763-8106
[email protected]